Trial intelligence / Profile preview

CEA RNA-pulsed Dendritic Cells in Resected Liver Metastases from Colon Cancer

NCT00003433Phase 2

Key facts

Status
Completed
Start
Jun 1998
Countries
1
Sponsor
Duke Cancer Institute
Modality
Whole Cell Cancer Vaccines, Dendritic Cell Vaccines, RNA Therapeutics
Conditions
colorectal cancer (CRC)
01

Overview

Phase 2, open-label, single-arm trial of carcinoembryonic antigen RNA-pulsed dendritic cells in colorectal cancer (CRC), sponsored by Duke Cancer Institute. Primary endpoint: Cellular immune response to CEA-pulsed dendritic cells at Week 8. Started Jun 1998; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • CEA RNA-pulsed dendritic cells

    Autologous dendritic cells pulsed with CEA RNA

03

Who it enrols

Patients with histologically confirmed adenocarcinoma of the colon metastatic to the liver that expresses CEA, who have undergone complete resection with no gross residual disease.

04

Endpoints

Primary

  • Cellular immune response to CEA-pulsed dendritic cells

Secondary

  • Overall Survival

  • Recurrence-Free Survival

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